Good news!
"... The Cord-Safe Study focused on infants born before 28 weeks of pregnancy – babies so small they could fit in the palm of your hand. Collecting cord blood from extremely preterm infants is no small feat. With smaller placentas, minimal blood volumes, and complex delivery circumstances, researchers face significant challenges in gathering these precious cells.
Despite these obstacles, the team managed to successfully collect and process cord blood cells from approximately 70 per cent of the extremely premature infants enrolled in the study.
Importantly, the study showed that 23 extremely preterm infants received cord blood-derived stem cell infusions with no serious adverse events reported, confirming that the procedure is safe and tolerable in this vulnerable population. ...
Premature babies are at high risk of brain injuries that can lead to lifelong challenges like cerebral palsy. By using their own cord blood cells, researchers believe they might be able to provide a natural “protective shield” for these vulnerable infants’ developing brains. ..."
"... researchers have discovered a potential new lifeline for the tiniest and most vulnerable newborns ... have successfully collected and reinfused umbilical cord blood cells in extremely premature babies, offering a glimmer of hope for preventing brain injuries. ...
The study builds on substantial preclinical evidence showing that umbilical cord blood-derived cells can be neuroprotective for the preterm brain. These cells have demonstrated multiple beneficial effects, including anti-inflammatory, immunomodulatory and protective mechanisms for the developing brain. ..."
From the abstract:
"Background
Evidence from preclinical studies in small and large animal models has shown neuroprotective effects of intravenous administration of umbilical cord blood derived cells (UCBCs). This study aimed to evaluate the feasibility of umbilical cord blood (UCB) collection, extraction of UCBCs, and subsequent safety of intravenous autologous administration of UCBCs in extremely preterm infants (born <28 weeks gestation).
Methods
A single-centre, open-label, single-arm, safety and feasibility clinical intervention trial was conducted at Monash Medical Centre and Monash Children's Hospital, Melbourne, Australia. Participants were extremely preterm infants born at less than 28 weeks completed gestation, and exclusions included major congenital malformation, maternal blood-borne virus infection, and severe brain injury on postnatal cranial ultrasound. UCB was collected at birth, and UCBCs were characterised (total nucleated cell count (TNC), mononuclear cell count (MNC), CD34+ cell count) and cryopreserved. Infants were reinfused with autologous UCBCs (25–50 million MNCs/kg) intravenously in the second postnatal week. Primary outcomes included feasibility: sufficient UCB volume (>7 mL) and UCBC numbers following processing (>25 × 106 TNCs/kg); and safety: absence of adverse events directly related to UCBC administration.
Findings
Forty-four UCB collections were attempted and sufficient UCB volume/UCBC extraction was demonstrated in 37 (84.1%) infants. Good Manufacturing Practice (GMP) grade cells were obtained in 31/44 (70.4%) of infants. Median (IQR) TNCs and MNCs collected were 130 (67–207) x 106/kg and 60 (39–105) x 106/kg, respectively. 23 infants with median (IQR) gestation of 26 (24–27) weeks and birth weight of 761 (650–946) grams were administered cells at a median (IQR) dose of 42.3 (31.1–62.3) x 106 MNCs/kg). No serious adverse events were noted, and the infusions were well-tolerated.
Interpretation
This phase-1 clinical trial has shown UCBC collection and reinfusion was feasible in approximately 70% of extremely preterm infants and was well tolerated without any serious adverse events. ..."
Stem Cells: Hope on the Horizon for Preterm Babies (original news release)
Feasibility and safety of autologous cord blood derived cell administration in extremely preterm infants: a single-centre, open-label, single-arm, phase I trial (CORD-SaFe study) (open access)
Absolutely amazing! "Rumaisa Rahman rests in her crib at Loyola University Medical Center in the US, three weeks after her birth ... born September 19, 2004 at 8.6 ounces, is one of the smallest known surviving babies. ..."
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